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Effect of Pistachio Intake on Insulin Resistance and Type 2 Diabetes Mellitus (EPIRDEM)

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ClinicalTrials.gov Identifier: NCT01441921
Recruitment Status : Unknown
Verified September 2011 by Dra Monica Bullo, Institut Investigacio Sanitaria Pere Virgili.
Recruitment status was:  Recruiting
First Posted : September 28, 2011
Last Update Posted : September 28, 2011
Sponsor:
Collaborator:
Western Pistachio Association
Information provided by (Responsible Party):
Dra Monica Bullo, Institut Investigacio Sanitaria Pere Virgili

Brief Summary:
Hypothesis: Chronic intake of pistachios improves glucose metabolism and insulin resistance status thus contributing to decrease the risk of type 2 diabetes mellitus and its associated abnormalities.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Dietary Supplement: Pistachios Other: control diet Not Applicable

Detailed Description:

In free-living overweight or obese adult with impaired fasting glucose or impaired glucose tolerance we will compare the effects of a pistachio-rich diet or a Mediterranean Diet on:

  • Fasting glucose levels, hemoglobin A1c, insulin, C peptide, HOMA IR, advanced glycation end products and soluble receptor of advanced glycation-end products.
  • Peripheral haemostatic parameters.
  • Plasma inflammatory markers.
  • Lymphocyte expression of toll-like receptors, C peptide, resistin and interleukin-6 in peripheral leukocytes.
  • Lymphocyte glucose transport and expression of glucose transporter 4 in peripheral blood leukocytes.
  • Platelet function including platelet number, mean platelet volume, platelet factor 4 levels and urinary 11-dehydro-thromboxane B2.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Effect of Pistachio Intake on Insulin Resistance and Type 2 Diabetes Mellitus
Study Start Date : September 2011
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Control diet
Low-fat normocaloric diet (30% fat, 55% carbohydrates, 15% proteins)
Other: control diet

Participants are randomised crossover clinical trial of 4-months trials separated by a 2-week washout period.

Total duration of intervention and follow-up is nine months.

Experimental: Pistachio diet
Diet supplemented with 2 ounces of pistachio (35% fat, 50% carbohydrates adn 15% protein)
Dietary Supplement: Pistachios

Participants are randomised crossover clinical trial of 4-months trials separated by a 2-week washout period.

Total duration of intervention and follow-up is nine months.




Primary Outcome Measures :
  1. Changes from baseline in circulating levels of glucose and insulin according to the intervention arm [ Time Frame: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm ]
    Measurement of circulating glucose and insulin levels and cellular glucose uptake


Secondary Outcome Measures :
  1. Changes from baseline in inflammatory, oxidative and metabolic risk markers related to glucose/insulin metabolism according to the intervention arm [ Time Frame: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm ]
    Cpeptide, resistin, IL-6, IL-18, Ghrelin, leptin, adiponectin, GLP-1 and oxidized LDL will be measured.

  2. Changes from baseline in haemostatic parameters according to the intervention arm [ Time Frame: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm ]
    Tissue factor, fibrinogen, PAI-1, vWF will be measured.

  3. Changes from baseline in HL and LDL size according to the intervention arm [ Time Frame: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm ]
    Plasmi lipoprotein size will be measured by polycacrylamide gradient gel electrophoresis

  4. Changes in advanced glycation end products according to the intervention arm [ Time Frame: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm ]
    Advanced glycation end products and soluble receptor of advanced glycation-end produtcs will be measured

  5. Changes from baseline in gene expression in the peripheral cells according to the intervention arm [ Time Frame: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm ]
    RNA from peripheral leukocytes will be isolated for the subsequent measurements of changes in gene expression of toll-like receptors, GLUT-4, C-peptide, resistin adn IL-6

  6. Changes from baseline in cellular glucose uptake according to the intervention arm [ Time Frame: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm ]
    Glucose uptake and GLUT4 protein levels will be assessed in peripheral leukocytes

  7. Changes from baseline in platelet function according to the intervention arm [ Time Frame: Participants will be followed for 9 months. Measurements will be done before and after 4 months of the first and second intervention arm ]
    Platelet number, mean platelet volume and platelet factor 4 in blood, and urinary levels of 11-dehydro-thromboxane B2 will be assessed.



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Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI less than 35 kg/m2.
  • Fasting plasma glucose levels between 100 and 125 mg/dl or
  • Oral glucose tolerance test of 140 to 199 mg/dl.

Exclusion Criteria:

  • Diabetes mellitus.
  • Alcohol, tobacco, or drug abuse.
  • Significant liver, kidney, thyroid, or other endocrine diseases.
  • Frequent consumption of nuts or known history of allergy to them.
  • Use of plant sterol, oral antidiabetic drugs, supplemental use of phyllium, fish oil supplements and multivitamins, vitamin E or other antioxidant supplements.
  • Bad dentures, implying difficulty to chew pistachios.
  • Being pregnant or wishing to become a pregnant 6 months before or during the study, lactating 6wk before or during the study.
  • Following vegetarian or weight loss diets.
  • Other medical or social conditions that difficult the compliance to the intervention.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01441921


Contacts
Contact: Monica Bullo, Dra. 977759312 monica.bullo@urv.cat

Locations
Spain
Human Nutrition Unit, Faculty of Medicine, Rovira i Virgili University Recruiting
Reus, Tarragona, Spain, 43201
Sponsors and Collaborators
Institut Investigacio Sanitaria Pere Virgili
Western Pistachio Association
Investigators
Principal Investigator: Monica Bullo, Dra. Institut Investigacio Sanitaria Pere Virgili

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dra Monica Bullo, Principal Investigators, Institut Investigacio Sanitaria Pere Virgili
ClinicalTrials.gov Identifier: NCT01441921     History of Changes
Other Study ID Numbers: PV11059S
First Posted: September 28, 2011    Key Record Dates
Last Update Posted: September 28, 2011
Last Verified: September 2011

Keywords provided by Dra Monica Bullo, Institut Investigacio Sanitaria Pere Virgili:
pistachio intake
insulin resistance
type 2 diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs